An intergroup randomised trial of rituximab versus a watch and wait strategy in patients with advanced stage, asymptomatic, non-bulky follicular lymphoma (Grades 1, 2 and 3a)
Description
Design:
The Watch and Wait study is a randomised phase III trial to determine whether giving treatment with rituximab to patients with advanced stage asymptomatic follicular lymphoma (grades 1, 2 and 3a) results in a significant delay in the initiation of chemotherapy or radiotherapy compared to the standard “watch and wait” approach, and the impact of each strategy on patients’ quality of life.
Treatment:
Patients will be randomised to receive either rituximab weekly for 4 weeks followed by 2 years of rituximab maintenance given every 8 weeks, or to a watch and wait policy. Patients will then be followed up every 2 months for a further 2 years and then annually thereafter. Patients will complete quality of life questionnaires at randomisation then every 2 months.
Key inclusion/exclusion criteria:
Patients must be aged 18 or over and have histologically proven follicular lymphoma grade 1, 2 and 3a. Patient must have stage II-IV disease and be asymptomatic without B symptoms or severe pruritus. Patients ECOG performance status must be 0-1 and they must have low tumour burden. Patients who are HIV positive or have hepatitis B infection are not eligible for the trial.
Duration of recruitment:
4 years
Aim
The aim of the Watch and Wait trial is to investigate whether rituximab can significantly delay the time to initiation of chemotherapy or radiotherapy in patients with newly-diagnosed, asymptomatic follicular lymphoma, and to explore the impact of this strategy on patients’ quality of life compared with a watchful waiting approach.